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The most basic of concepts, and yet the least exible until now

Intensive user testing over a one month period guaranteed smooth, efficient system validation and going live without deviations or surprises. This period was assigned to user training, SOP drafting and finalising, as well as approving the validation documentation without disturbing ongoing production.
Seamless System Validation

According to a Schering-Plough project team member, one of METTLER TOLEDO's biggest strengths was that the validation process was fast, efficient and non-disruptive. It is an absolute requirement that all systems marketed to the pharmaceutical industry undergo a strict validation process. Under normal circumstances, the validation process is time-consuming and requires close supervision by experts. Because METTLER TOLEDO supplied the protocols for the equipment and software acquired by Schering-Plough, the time required was significantly reduced compared to beeing developed from scratch. Also, METTLER TOLEDO has comprehensive validation manuals for its products that further accelerate the validation process. Validation Manual 1 provided supplier audit information of METTLER TOLEDO for DQ, while Validation Manual 2 provided the validation protocol for IQ and OQ. These validation protocols were made according to the GAMP4 guidelines, and translated into Japanese for further ease of use. Schering-Plough project members were also impressed by the efficiency and ability of the METTLER TOLEDO Applied Software and Consulting (MTASC) group, who helped guide the team safety through all the validation process whilst providing consulting support. Overall, Schering-Plough project members were satisfied with the products and services rendered, agreeing unanimously that the entire validation process was seamless, efficient and timesaving.

Accurate weighing has been a fundamental basis for trading, bartering and payment for goods or services. Consistent weighing also forms the basis for assuring the correct formulation of compounds used in the food we eat, inks and dyes used to print cookbooks we read, and making wines and spirits we drink, to the pharmaceuticals used to treat the upset stomachs or headaches we suffer from the next morning. Proper, precise, and consistent calibration of a scale forms the basis of all accurate weighing. The use of known masses (test weights) in the calibration process has been used to establish performance of a scale since the first balances were checked or regulated by government officials. Regular checking of scales helps to assure that consistent performance is maintained over long periods of time. Sometimes, the installation dynamics or mechanical integrity of the scale design is not as robust as desired. As weight is added to a vessel or container, the supporting structure may bend or flex, resulting in the non-linear performance of the scale. In order to offset these mechanical characteristics, intermediate points (between zero and the capacity of the scale) can be used to linearise the performance. This process is known as linearity adjustment. These two techniques and calibration processes are commonly available with electronic weighing terminals, but have also often been the only ways to calibrate a scale.


IndMagazine 1/2006


METTLER TOLEDOs IND560 introduces a variety of new ways to calibrate and check the scale's performance, allowing you to align the most appropriate technique (or process) with your real requirements.
Step Calibration automates a field technique used when the capacity of a scale is much larger than the available test mass. The substitution method of calibration uses a known test mass to calibrate a small portion of the scale's weighing capacity. After calibration of this portion is established, the test load is removed, and a substitute material is placed inside the vessel or hopper to a point near the calibrated load. The test mass is then added to this value, and a new calibration point is established. The process is repeated until the last calibration point is near the scale's capacity. This process required that the scale technicians to manually calculate each successive calibration value and enter the appropriate figures into the terminal, making it prone to entry or computational error. The Step Calibration process automates the procedure, guiding the technician through each step and eliminating the need to do the math or enter values. CalFree is a combination of a field

to produce an identical output for a given input. The combination of these two processes allows an installer to compute the theoretical calibration of a given scale. This technique is not as accurate as using test weights, since it does not take into account the actual mechanical characteristics of the installed scale. However, many system integrators and installation technicians only need an approximation of calibration to prove the operational integrity of the overall system. In addition, factory calibrated analogue sections also allow you to replace boards and be assured that the calibration of the replacement is identical to that of the board being replaced.
Cal Test and Calibration Maintenance

used to initiate the Cal Test at specific intervals, either based on time or the number of weighments. If the Cal Test fails, a message can be generated and logged, the scale can be turned off or no action taken. Using these two processes can help you ensure compliance with validation requirements dictated by your quality system.
Step Calibration and CalFree are two

calibration technique and factory controlled quality assurance process. During the production of a load cell, the actual gain of the cell is measured and recorded. In addition, each terminal's analogue measurement section is calibrated

are two patent pending techniques that help you assure the calibration of your scale is within tolerance over long periods of time. Cal Test is a sequence of up to 25 steps where an operator is directed to place test weights in specific locations. The weight produced at each step is compared against the test mass used and found to be within or outside of a given tolerance. Calibration Maintenance is

new, innovative techniques that help you align the appropriate calibration technique with your real requirements, balancing accuracy with time, cost and practicality. Cal Test and Calibration Maintenance can perform a vital role in assuring your weighing accuracy is maintained and that compliance with your internal quality requirements is achieved.

IndMagazine 1/2006